Evaluation of EarlySense Home Care Tele-monitoring Device -For Early Detection of Deterioration For Cardiac Patients at Home

Study Protocol for Evaluation of EarlySense Home Care Tele-monitoring Device - A Contact-Free System for Measuring Heart Rate, Respiratory Rate and Motion For Early Detection of Deterioration For Cardiac Patients at Home

The aim of this study is to evaluate the relevance of the information as provided by the EarlySense Home care Tele-monitoring system can provide relevant flagging information for clinicians to identify the patients at higher risk to proactively assess patients' condition

Study Overview

• Status: Completed
• Conditions: Post Cardiac Surgery

Detailed Description

Study objectives include:

1. Assess if and to what extent the flags provided by EarlySense Home care tele-monitoring provides relevant clinical information that can help case managers / nurses of home care agency to detect patients who need further assessment and perhaps early intervention to minimize hospitalization (re-admission to hospital).
2. Use data to further optimize a decision algorithm utilizing changes in physiological data over time (i.e., hours to days) which may identify patients at higher risk for poor outcomes (flagging algorithm).
3. Assess the acceptability of the EarlySense Home care device by clinicians
4. Assess the acceptability of the EarlySense Home care device by patients at home and their families, in their own home as determined by a provided questioner

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Post Cardiac Surgery

Description

Inclusion Criteria:

• Age 21 and up
• Any patient hosted in Shelev with geographically resident over 50 km from Sheba Medical Center/ Shelev
• Patients agrees to sign the consent form and comply with study protocol.

Exclusion Criteria:

• Patients do not agree to sign the consent form
• Planned readmission within 30 days of discharge from hospital
• Going home to hospice care.
• Patients with cognitive constraints or disabilities

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate if Alerts and Flags generated by the EarlySense Home Care System, could have potentially prevented readmission to hospitals, and providing better care at home, for post cardiac surgery patients	Evaluate the usability of Home Monitoring System for Heart Rate (BPM), in providing help to nurses, evaluating the overall clinical situation of post cardiac petients at home	30 days
To evaluate if Alerts and Flags generated by the EarlySense Home Care System, could have potentially prevented readmission to hospitals, and providing better care at home, for post cardiac surgery patients	Evaluate the usability of Home Monitoring System for Respiratory Rate (Br./min), in providing help to nurses, evaluating the overall clinical situation of post cardiac petients at home	30 days
To evaluate if Alerts and Flags generated by the EarlySense Home Care System, could have potentially prevented readmission to hospitals, and providing better care at home, for post cardiac surgery patients	Evaluate the usability of Home Monitoring System for activity indication such asnumber of bed exits during nighttime in providing help to nurses, evaluating the overall clinical situation of post cardiac petients at home	30 days
To evaluate if Alerts and Flags generated by the EarlySense Home Care System, could have potentially prevented readmission to hospitals, and providing better care at home, for post cardiac surgery patients	Evaluate the usability of Home Monitoring System activity indication such as number of hours spent in bed during the day in providing help to nurses, evaluating the overall clinical situation of post cardiac petients at home	30 days

Collaborators and Investigators

• Sponsor: EarlySense Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: December 28, 2015
• First Submitted That Met QC Criteria: January 16, 2016
• First Posted (Estimate): January 21, 2016

Study Record Updates

• Last Update Posted (Actual): August 2, 2017
• Last Update Submitted That Met QC Criteria: August 1, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CLN-H-003-2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided